This invention relates generally to devices for the treatment of ear disorders, and more particularly to an apparatus and system for treating eustachian tube dysfunction.
Ear infections are a significant problem worldwide. They are typically caused by eustachian tube dysfunction, which prevents adequate aeration of the middle ear space. Pediatric patients are especially prone to this problem due to shorter eustachian tube length, which facilitates bacterial migration, and a decreased angle between the middle ear and the nasopharynx, which prevents proper aeration. Chronic infections can result in decreased hearing and in turn poor speech and language development, or potentially middle ear disease requiring surgical intervention. Chronic ear infections also account for many lost days of work and school. The estimated societal cost for this disease is estimated at $4-5 billion per year in the United States alone.
The current treatment for patients with ear infections (xe2x80x9cotitis mediaxe2x80x9d) is both medical and surgical. Medical therapy relies primarily on antibiotic use, both for episodes of acute infection and as a long-term prophylactic measure. The implications of long-term antibiotic use are the development of a significant increase in antibiotic resistance, reported as a significant concern in recent studies. Surgical therapy is commonly employed for patients who have failed medical therapy and for patients prone to repeat infections such as those with cleft deformities. Surgery for ear infections relies primarily on the placement of a tube into the middle ear space, which permits adequate aeration. While this technique is highly effective therapy for ear infections, a general anesthetic (with its associated risks) is commonly required in the pediatric population. After the surgery, precautions are required to ensure that fluid or bacteria do not enter the middle ear space through the external auditory canal. Additionally, multiple sets of tubes are often required before a child outgrows their susceptibility to infection.
Despite the prevalence of acute and chronic ear infections, the current treatment methods are essentially limited to antibiotics and surgical tube placement. No treatment to date has successfully focused on direct attempts to correct the physiological problem of inadequate aeration of the middle ear space. Anatomically, the eustachian tube is a cartilaginous structure with dilation controlled by the tensor villi palatine muscle which originates on the eustachian tube and inserts into the midline of the soft palate. When the muscles of the soft palate contract during swallowing, the tensor villi palatine muscle dilates the eustachian tube. Several conditions can prevent such normal eustachian tube opening. However, direct or indirect stimulation of the soft palate can induce eustachian tube dilation and therefore serve as a treatment for ear infections.
Attempts to stimulate the soft palate have relied primarily upon electromuscular stimulation, with electrodes placed in contact with the palate using a device similar to a retainer. Such devices have predominantly been employed for the treatment of snoring and sleep apnea, and have not generated any significant market appeal. This failure is probably due to the fact that the electrical energy required to induce direct palatal stimulation is painful. This makes such an approach a particularly inappropriate one for the pediatric population.
What has been needed is a device that stimulates the muscles of the soft palate comfortably and effectively, thereby reducing or eliminating the need for antibiotic or surgical treatments for ear infections.
In one aspect of the invention, an apparatus for inducing stimulation of muscles within the mouth comprises a housing, a muscular contact member, a vibrating device, and a controller. The muscular contact member extends from the housing, is for insertion into the mouth, and is configured to contact muscles within the mouth. The vibrating device cooperates with the controller and muscular contact member to transmit vibration to the muscular contact member and in turn to muscles within the mouth.
In another aspect of the invention, a system for inducing stimulation of muscles within the mouth comprises a rechargeable apparatus and a storage base for receiving the rechargeable apparatus. The rechargeable apparatus is for inducing stimulation, and includes a housing having a rechargeable battery. The rechargeable apparatus also includes a vibrating device powered by the battery and a muscular contact member. The vibrating device transmits vibration to the muscular contact member. The storage base receives the rechargeable apparatus when it is not in use, and includes a battery charger for charging the battery.
In another aspect of the invention, a method using an apparatus or system, such as those described above, may be employed to treat various disorders.
These and other advantages and features of novelty which characterize the invention are pointed out with particularity in the claims annexed hereto. However, for a better understanding of the invention and its advantages, reference should be made to the drawings which form a further part hereof, and to the accompanying descriptive matter in which there are illustrated and described preferred embodiments of the invention.